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Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03897686
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Research Centre BIOFORM

Brief Summary:
The aim of this double-blinded controlled study is to assess clinical efficacy and safety of intra-articular polyacrylamide hydrogel with ions of silver in comparison with placebo (0.9% sodium chloride solution) in Kellgren Lawrence radiological grade II-III knee osteoarthritis

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: hydrous biopolymer with silver ions "Argiform" Device: saline solution Not Applicable

Detailed Description:
Polyacrylamide hydrogel (hereinafter - PAHG) is intended for a symptomatic effect leading to the decrease of joint pain intensity and improvement of functional joint characteristics. Therefore PAHG is intended for symptom-modifying therapy of joint osteoarthritis (hereinafter - OA). The aim of this study is to estimate efficacy and safety of intra-articular injections of PAHG in comparison with saline solution. Men and women above 50 years with verified knee osteoarthritis in accordance with the ACR criteria will be randomized 2 groups depends on treatment (PAHG or saline solution). Each patient will receive to the target knee joint 4.0 ml for one injection either PAHG or placebo with one-week interval between injections. Course - 2 injections. To avoid the joint overfilling with the dense, slowly resorbing material, with a good clinical result, the course of injections will be stopped. Primary and secondary efficacy endpoints, and safety parameters will be assessed on visits on Week 6, 13 and 25.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter double-blind randomized comparative placebo-controlled
Masking: Double (Participant, Investigator)
Masking Description: A patient, study investigator and Sponsor representative (monitoring specialist) will not know to which group a patient is included. to preserve blinding of any patient and study team, an independent unblended physician is to be engaged, he/she will receive the product per randomization code and perform the procedure of intra-articular injection of the study MD and placebo.
Primary Purpose: Treatment
Official Title: Multicenter Double-blind Randomized Comparative Placebo-controlled Study of Efficacy and Safety of Intra-articular Polyacrylamide Hydrogel With Silver Ions (NOLTREX™) in Knee Osteoarthritis
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: NOLTREX™, II-III grade OA
64 patients with II-III grade of gonarthrosis will randomised to receive PAHG
Device: hydrous biopolymer with silver ions "Argiform"
4.0 ml for one injection with one-week interval between injections. Course - 2 injections.
Other Names:
  • polyacrylamide hydrogel with ions of silver
  • Synovial fluid endoprosthesis NOLTREX™

Placebo Comparator: Placebo, II-III grade ОА
64 patients with II-III grade of gonarthrosis will randomised to receive saline solution
Device: saline solution
4.0 ml for one injection with one-week interval between injections. Course - 2 injections.




Primary Outcome Measures :
  1. Change of the total WOMAC score (WOMAC-T) [ Time Frame: at Week 25 in comparison with baseline at Week 1 ]
    Estimated per the corresponding subscales and total arthritis index score developed by WOMAC


Secondary Outcome Measures :
  1. The total score [ Time Frame: at Week 13 in comparison with baseline at Week 1 ]
    Change of the total score of WOMAC scale (WOMAC-T)

  2. The pain [ Time Frame: at Week 6, Week 13 and Week 25 and in comparison with baseline at Week 1 ]
    Change of the pain subscale score (WOMAC-A)

  3. The rigidity and functionality [ Time Frame: at Week 6, Week 13 and Week 25 and in comparison with baseline at Week 1 ]
    Change of rigidity (WOMAC-B) and functionality (WOMAC-C) subscale scores

  4. Patient's assessment of the treatment efficacy [ Time Frame: Week 6, Week 13 and Week 25 ]
    per scale from 1 - evident aggravation to 6 - significant improvement

  5. Investigator's assessment of the treatment efficacy [ Time Frame: Week 6, Week 13 and Week 25 ]
    per scale from 1 - evident aggravation to 6 - significant improvement

  6. Assessment of the total number of paracetamol tablets taken [ Time Frame: Week 6, Week 13 and Week 25 ]
    the need in paracetamol intake to relieve the knee pain during administration of intra-articular MD NOLTREX™ in comparison with placebo

  7. Patient withdrawal rates due to safety [ Time Frame: Week 25 ]

    Proportion of patient who left the study due to:

    • Need in paracetamol intake due to knee osteoarthritis 4 days a week and more during 2 successive weeks;
    • The investigator makes the decision that a patient should discontinue the study in the best interests of the patient;
    • Individual intolerability or contraindications to the test MD, placebo or paracetamol;
    • AE/SAE which requires examination and/or treatment affecting significantly the study procedures (in particular, in particular, development of active arthritis or hemarthrosis of the target knee joint).

  8. Patient withdrawal rates due to poor patient's treatment compliance [ Time Frame: Week 25 ]

    Proportion of patient who left the study due to:

    • Informed consent withdrawal (patient's unwillingness to continue the study);
    • Major deviation from the study protocol.

  9. Intensity of pain in the target knee joint (100-mm VAS) [ Time Frame: Week 1, Week 2 ]
    Assessment of pain intensity in the target knee joint per mm visual analogous scale (100-mm VAS)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Verified knee osteoarthritis in accordance with the ACR (knee pain combined with one of the following signs: age above 50 years, knee crepitus or morning joint stiffness lasting for less than 30 minutes combined with radiologic signs of knee osteoarthritis);
  • Kellgren Lawrence radiological grade II-III knee osteoarthritis with the predominant involvement of the medial tibiofemoral region of the knee joint;
  • Joint space width (JSW) of the target knee joint at least 2.5 mm.

Exclusion Criteria:

  1. History of any injury or surgical intervention on the target knee joint (except for diagnostic arthroscopy made not longer than 60 days at the study entry);
  2. Severe degenerative changes in the target knee joint determined as the joint space narrowing less than 2 mm;
  3. Varus or valgus deformation of the target knee joint;
  4. Instability of the target knee joint;
  5. Active inflammation of the target knee joint (edema, hyperemia, present effusion) at the study entry;
  6. Microcrystalline arthropathies;
  7. Systemic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, etc.);
  8. Seronegative spondyloarthritis and reactive arthritis;
  9. Inflammatory diseases of the skin and soft tissues in the proposed injection site for the test MD or placebo in the target joint;
  10. History of venous thrombosis and thromboembolia;
  11. Coagulogram abnormalities (APTT, prothrombin time, prothrombin index, fibrinogen);
  12. Inflammatory changes in the complete blood count (leukocytosis, increase of erythrocyte sedimentation rate [ESR]);
  13. Platelet count abnormality (in accordance with the reference ranges of the local laboratory;
  14. Increase of rheumatoid factor level;
  15. Increase of uric acid level > 360 μmol/l;
  16. Diabetes mellitus;
  17. Hemophilia and other hemorrhagic diatheses, as well administration of anticoagulants and disaggregants;
  18. Positive results of HIV, HBs-Ag, anti-HCV, RW tests;
  19. Intra-articular injection to the target knee joint:

    • Noltrex - within 24 months prior patient's inclusion to the study;
    • hyaluronates - within 6 months prior patient's inclusion to the study;
    • glucocorticosteroids - within 1 month prior the study inclusion;
    • non-steroidal anti-inflammatory drugs (NSAID) - within 3 weeks prior patient's inclusion to the study.
  20. Oral administration of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks prior the study inclusion;
  21. Necessity of systemic glucocorticosteroids in any dosage form;
  22. Paracetamol administration within 48 hours prior the study inclusion;
  23. Pregnancy and lactation;
  24. Hypersensitivity to components of the test MD or placebo;
  25. Severe liver disorder determined as the increase of one of the values: ALT, AST, ALP, total bilirubin, GGTP more than 3 times the upper limit of normal;
  26. Renal diseases with the glomerular filtration rate estimated per Cockraft-Gault formula less than 60 ml/min/1.73 m2 (III-V stage chronic renal disease [CRD]);
  27. Clinically manifest hip osteoarthritis;
  28. History of knee and coxofemoral endoprosthesis;
  29. Acute infectious diseases or infectious aggravations of chronic diseases (respiratory infections) within one month prior the study inclusion;
  30. Severe decompensated chronic or acute diseases and other conditions which, by the opinion of the study physician, may preclude the patient's participation in the study or affect the study results.

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Responsible Party: Research Centre BIOFORM
ClinicalTrials.gov Identifier: NCT03897686     History of Changes
Other Study ID Numbers: IA/PAAG-SI/OA/2019
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Research Centre BIOFORM:
intra-articular
polyacrylamide hydrogel
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions